The HRA report does not exonerate the PACE trial, it merely confirms that its Research Ethics approval was in order

The UK’s Health Research Authority have released a report on their assessment of the beleaguered PACE Trial, and have concluded that they are happy with it.

Cue the usual well-paid, eminent, professorial figures haughtily patronizing the great unwashed with their I-told-you-so put-downs and human webs of self-congratulatory mutual back-slapping.

You know the drill. Patients, scientists, academics, advocates, and public representatives point out glaring errors in the PACE Trial design — errors that would return a failing grade in an undergraduate research methods assignment — and call on regulatory bodies to withdraw their approvals accordingly.

Meanwhile, the PACE Trial’s authors, together with their extensive network of professional contacts (which in a place like the UK is so intertwined, convoluted, and overlapping as to make genuine peer-review a real practical challenge) chime together to defend what is literally bad science and, moreover, to condemn those who criticize it as amateurs, upstarts, and know-nothings.

It’s a true class system. The aristocracy have produced their PACE Trial, as befits their status as well-off denizens of civil society. The patients — those proles — must shut up and learn to know their place.

Now that the HRA say they are happy with PACE, the aristocrats have been crowing, as aristocrats are wont to do.

However, it is worth paying close attention to what the HRA set out to do here. See, for example, their own very words (emphasis added by me):

In assessing the HRA’s findings, it is important to remember that the agency’s remit is relatively narrow—it focuses on process. As the report notes: “Our concern as a regulator is whether the study was properly approved by the Research Ethics Committee (REC).”

The report includes this important disclaimer: “It would not be appropriate for the HRA to seek to resolve…debates about the quality of the study. Discussion of the meaning and robustness of results is how science is expected to proceed.

And this: “We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and sowe are not in a position to comment on them.”

In short, the HRA do NOT find that all with the PACE Trial is ay-yippety-eye-okay.

They do not find this because they do not even try to find it. Let me — or, rather, letthem — repeat the point:

“We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and so we are not in a position to comment on them.”

Here it is again in larger font:

“We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and so we are not in a position to comment on them.”

The good news of course is that several other authoritative figures have been “in a position” to comment on these criticisms, and have done so very extensively.

Academics, scientists, and researchers — even professors — carry ethical obligations to ensure that facts are conveyed accurately to audiences at all times. The HRA report simply does not vindicate the rigour or soundness of the methods used in PACE, or the soundness of its research design. The HRA report simply assesses whether the trial met the requirements of research ethics committee approval at the sites where it was carried out.

Anyone who uses this report to imply anything other than that the relevant paperwork was filed correctlyis misrepresenting the role of the HRA and the scope of their review.

If this is not stated clearly by those with vested interests in the PACE Trial, then I really do hope it is as a result of genuine human error on their part. After all, everyone is subject to human fallibility (even aristocrats).

Anything else would constitute a deliberate effort to mislead, and would be — simply — shameful.

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In Australia the first draft of a report prepared for our lead research body uses the fact that the paperwork was filed correctly to “whitewash” the PACE trials flaws and faults. Any comments to this panel about the flaws and faults in this report (there are many) from anyone, anywhere would be gratefully received. https://consultations.nhmrc.gov.au/public_consultations/mecfs-2019a

One can almost smell the fear. Not only is the HRA trying to cover its own hindquarters, but it is calling for an examination of PACE criticisms by someone, anyone but them. A crown prosecutor, perhaps?